PMA · Approved
ApprovedSharps Terminator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharps Terminator, LLC · MTV Sharps Needle Destruction Device
Approved on Feb 17, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 1,212-day review. 1 later device descends from it.
- Decided
- Feb 17, 2016
- Review
- 1,212 days
- Class
- Class II
- Product code
- MTV
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceP120018 Sharps TerminatorSharps Terminator, LLC · 2016
- Descendant · cites it directly · 0 of its ownK202073 NeedleSmart Professional (NS Pro)Needlesmart Limited · 2021
Most influential descendants
Showing 1 of 1 · See all- K202073NeedleSmart Professional (NS Pro)Needlesmart Limited · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P120018 | Sharps Terminator | Sharps Terminator, LLC | 2016 | — |
| +1 | K202073 | NeedleSmart Professional (NS Pro) | Needlesmart Limited | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MTV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MTV device
- #1 K202073 NeedleSmart Professional (NS Pro)score 1.1 · 1 generation · no Class I recall
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202073 | NeedleSmart Professional (NS Pro) | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K202073 (Needlesmart Limited, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MTV devicesMTV Sharps Needle Destruction Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MTV
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MTV
Too few MTV 510(k)s in any year since 2007 to give a median.
Recalls per year · MTV
No recall names MTV since 2007.
Adverse event reports per year · MTV
No MAUDE report names MTV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P120018 · printed Nov 6, 2026
Cite this page
510(k) Report. “P120018: Sharps Terminator.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P120018
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026